FDA.reportPublic FDA data

Antibacterial Gold

Product NDC
67510-0016
11-digit product format
675100016
Labeler code
67510
Product ID
67510-0016_b1933159-1485-4898-b563-61e4efece407
Type
HUMAN OTC DRUG
Nonproprietary name
Triclocarban
Dosage form
SOAP
Route
TOPICAL
Labeler
Kareway Product, Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-09-07
Marketing end
0000-00-00
Substance
TRICLOCARBAN
Active strength
0 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-0016-22019-11-27C16284748780-19855d018-d33a-cd31-e053-dbdaa90ab51aDrug Facts
67510-0016-32019-11-27C16284748780-19855d018-d33a-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0016-2Antibacterial Gold100 g in 1 BOXSOAP1002
67510-0016-2Antibacterial Gold2 in 1 CELLO PACKSOAP22
67510-0016-3Antibacterial Gold100 g in 1 BOXSOAP1002
67510-0016-3Antibacterial Gold3 in 1 CELLO PACKSOAP32

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOCARBANACTIVE INGREDIENTBGG1Y1ED0YANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
TRICLOCARBANACTIVE MOIETYBGG1Y1ED0YANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
D&C YELLOW NO. 8INACTIVE INGREDIENT93X55PE38XANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
ETIDRONATE TETRASODIUMINACTIVE INGREDIENTCZZ9T1T1X4ANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLXANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1ANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
PEG-6 METHYL ETHERINACTIVE INGREDIENTWXH089JZ5EANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
PENTASODIUM PENTETATEINACTIVE INGREDIENT961TOZ5L7TANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
SODIUM PALM KERNELATEINACTIVE INGREDIENT6H91L1NXTWANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
SODIUM PALMITATEINACTIVE INGREDIENTJQ43KP6296ANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0016ANTIBACTERIAL GOLD (TRICLOCARBAN) SOAP [KAREWAY PRODUCT, INC.]2Legacy NDC, 4 package rows20121101_4f3f6661-3275-4971-b1dc-f6fc30c64e3a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1150107triclocarban 0.1 % Medicated Bar SoapPSN4f3f6661-3275-4971-b1dc-f6fc30c64e3a2
1150107triclocarban 0.001 MG/MG Medicated Bar SoapSCD4f3f6661-3275-4971-b1dc-f6fc30c64e3a2
1150107triclocarban 0.1 % Medicated Bar SoapSY4f3f6661-3275-4971-b1dc-f6fc30c64e3a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67510-0016-267510001602100 g in 1 BOX100 gHistorical
67510-0016-367510001603100 g in 1 BOX100 gHistorical